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ANBL1232: Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-High Risk Neuroblastoma

About this study

Neuroblastoma (NBL) is a type of cancer that occurs in nerve cells outside of the brain. Treatment for NBL is determined by certain risks factors including: The tumor stage, which is based on whether the tumor has stayed in one place or if it has spread to other parts of the body, the child’s age at diagnosis, and the biologic features of the tumor. Currently the standard therapy for non-high risk NBL or ganglioneuroblastoma includes surgery alone to remove the tumor or chemotherapy to make the tumor smaller followed by surgery. Although this approach results in excellent cure rates there is evidence that some of these patients may not need surgery or chemotherapy. This study enrolled participants less than one year of age who had a small mass (tumor) that was not involving other vital structures and was believed to be a non-high-risk neuroblastoma (NBL) or ganglioneuroblastoma or patients up to 18 months of age with tumors whose tumors had limited involvement of other vital structures or had spread to skin, liver or bone marrow (small amount). In this study, participants were enrolled in 1 of 3 groups; Group A, Group B, or Group C. Group assignment was based on the aforementioned risk factors. The overall goal for all participants in all groups in this study is to see if the doctors can treat non-high-risk NBL by either not doing surgery or by reducing the amount of chemotherapy given and still get very good results.

Objectives

  • To eliminate therapy as the initial approach for infants less than twelve (12) months of age with small INRG Stage L1 neuroblastoma while maintaining an overall survival (OS) of ninety-nine (99) percent
  • To eliminate therapy as the initial approach for non-high-risk patients less than eight-teen (18) months of age with localized neuroblastoma and favorable biology (histologic and genomic features) while maintaining an OS of ninety-nine (99) percent
  • To achieve a three (3) year overall survival of greater than eighty-one (81) percent for infants less than eight-teen (18) months of age with INRG Stage Ms neuroblastoma using objective criteria for early initiation of a response-based treatment algorithm

Eligibility overview

Inclusion Criteria Group A:

  • Participant had been enrolled on ANBLB1 (ANBL00B1).
  • Participant was newly diagnosed MYCN non-amplified neuroblastoma or MYCN non-amplified ganglioneuroblastoma.
  • Participant diagnosis had been verified by histology.
  • Participant was less than twelve (12) months (less than 365 days) of age at diagnosis.
  • Participant had newly diagnosed INRG Stage L1 neuroblastoma whose tumor is < 5 cm in greatest diameter.
  • Participant had no prior tumor resection or biopsy.

Inclusion Criteria Group B:

  • Participant had been enrolled on ANBLB1 (ANBL00B1).
  • Participant had newly diagnosed MYCN non-amplified neuroblastoma or MYCN non-amplified ganglioneuroblastoma.
  • Participant diagnosis had been verified by histology.
  • Participant was less than eight-teen (18) months (less than 547 days) of age at diagnosis.
  • Participant had newly-diagnosed INRG Stage L2 neuroblastoma (no life threatening symptoms or impending neurologic or other organ function compromise.

Inclusion Criteria Group C:

  • Participant had been enrolled on ANBLB1 (ANBL00B1).
  • Participant had newly diagnosed MYCN non-amplified neuroblastoma or MYCN non-amplified ganglioneuroblastoma.
  • Participant diagnosis had been verified by histology.
  • Participant was less than eight-teen (18) months (547 days) of age and has newly diagnosed INRG Stage Ms neuroblastoma.
  • Participant had received no prior radiotherapy or chemotherapy, with the exception of dexamethasone.

Exclusion Criteria:

  • Participant had MYCN amplified tumor.
  • Group B or C participant who did not enroll on this study within four (4) weeks of definitive diagnostic procedure.
  • Group A or C participant not required to undergo tumor biopsy, who did not enroll on this study within four (4) weeks of confirmatory imaging study.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

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Overview

Full title:

Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma (ANBL1232)

Study goal:

The overall goal for this study is to see if the doctors can treat non-high-risk NBL by either not doing surgery or by reducing the amount of chemotherapy given and still get very good results.

Diagnosis:

Neuroblastoma, ganglioneuroblastoma

Age:

Less than 12 months or less than 18 months at time of diagnosis, depending on inclusion criteria.

Clinical trials categories:

Childhood Cancer Neuroblastoma

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